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Completed

NCT Number: NCT05524220

Effect of Nasal Positive Airway Pressure Versus Standard Care on Oxygenation and Ventilation During Propofol-based Sedation for Colonoscopy in Patients With High Risk of Airway Obstruction

The purpose of this study is to to compare oxygenation and ventilation on spontaneously ventilating obese patients or those with diagnosed or undiagnosed Obstructive sleep apnea (OSA) undergoing day colonoscopy under Propofol based sedation, between the SuperNO2VA Et™ nasal positive airway pressure (PAP) device and routine care with face mask for oxygen (O2).

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Key information

Conditions

Obstructive Sleep Apnea, Obesity Apnea Body Weight Dyssomnias Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing colonoscopy
  • American Society of Anesthesiology (ASA) Physical Status I-III
  • BMI ≥30 kg/m2 or suspected Obstructive Sleep Apnea

Exclusion criteria

  • Inpatient status
  • Active Congestive Heart Failure Exacerbation
  • Untreated ischemic heart disease
  • Acute exacerbation of respiratory disorders, including Chronic obstructive pulmonary disease (COPD) and asthma
  • Emergent procedures
  • Pregnancy
  • Previous enrollment in this study
  • Inability to provide informed consent
  • Additional medical testing planned for the same day
  • History of allergic reaction to Propofol
  • Tracheostomy
  • Supra-glottic or sub-glottic tumor
  • Gastrointestinal tract obstruction or delayed transit (including delayed gastric emptying, gastric bezoar, achalasia, toxic megacolon).
  • Prisoners
  • Unable to fit SuperNoVa

Treatment and study plan

Standard care with a facemask.

Device

The anesthesia provider will supply oxygen via the closed facemask at 10 liters per minute (LPM)

SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus)

Device

The anesthesia provider will attach the SuperNO2VA™ EtCO2 circuit port to the hyperinflation bag with the oxygen flow rate to 10 L/min. The oxygenation, continuous positive airway pressure, and ventilation of the subject will be done via SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus)

Primary outcomes

  1. Time Taken From Initiation of Induction to the First Airway Intervention

    Time frame: From Initiation of Induction to the First Airway Intervention (about 16 minutes)

Secondary outcomes

  1. Amount of Propofol Administered During Induction

    Time frame: Within 5 minutes of the start of anesthesia

  2. Total Amount of Propofol Administered During the Procedure

    Time frame: during the procedure (about 45 minutes)

  3. Change in Alertness of Subject as Assessed by the Modified Observer's Assessment of Alertness/Sedation Scale (MOAAS)

    Time frame: prior to endoscopic intubation,during the procedure

    This is scored from 0(no response)-5(response to your name spoken in a normal tone), a higher number indicating more alertness

  4. Time Taken From Induction to Endoscopic Insertion

    Time frame: within 10 minutes of start of sedation

  5. Incidence of Procedural Interruptions as Assessed by the Number of Times the Endoscope is Removed From the Patient

    Time frame: From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes)

  6. Duration of Procedural Interruptions as Assessed by the Length of Time the Endoscope is Removed From the Patient

    Time frame: From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes)

  7. Number of Participants Who Received Airway Maneuvers

    Time frame: From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes)

  8. Time Taken for Airway Maneuvers

    Time frame: From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes)

  9. Reason for Airway Maneuvers

    Time frame: From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes)

  10. Time Taken for the Entire Procedure

    Time frame: from start of procedure to end of procedure (about 45 minutes)

  11. Recovery Time as Assessed by the Time When Subject Was Ready for Discharge

    Time frame: at time of discharge( about one hour from end of procedure)

  12. Recovery Time as Assessed by the Actual Time When Subject Was Discharged

    Time frame: at time of discharge( about one and a half hour from end of procedure)

  13. Patient Satisfaction as Assessed by the Visual Analog Scale (VAS)

    Time frame: at time of discharge(about one hour from end of procedure)

    This will be scored from 0-10, a higher score indicating more satisfaction

  14. Number of Participants That Tolerated the SuperNO2VA™EtCO2

    Time frame: from start of procedure to end of procedure (about 45 minutes)

  15. Anesthesiologist Satisfaction Score as Assessed by the Visual Analog Scale (VAS)

    Time frame: end of procedure (about 45 minutes from start)

    This will be scored from 0-10, a higher score indicating more satisfaction

  16. Number of Participants That Had Incidences of Cardiac Complications

    Time frame: during the procedure (about 45 minutes)

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Vyaire Medical

Registry information

Official study title

Effect of Nasal Positive Airway Pressure Versus Standard Care on Oxygenation and Ventilation During Propofol-based Sedation for Colonoscopy in Patients With High Risk of Airway Obstruction: a Prospective Randomized Controlled Trial.

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 1, 2022
Registry last updated
Apr 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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